# K973650: Troponin (Trop) Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Oct 20, 1997 after 25 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Most influential descendants
- K020662: Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calibrators (2002), 1 descendant of its own
- K033745: Ramp Troponin I Assay (2004), 0 descendants of its own
- K031031: Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators (2003), 0 descendants of its own
- K024193: Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/Calibrators (2003), 0 descendants of its own
- K992366: Vitros Immunodiagnostic Products Troponin I Reagent Pack (1999), 0 descendants of its own

## Indications for use
The TROP method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure cardiac troponin-I in serum and plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Source page: https://510kreport.com/device/K973650
Methodology: https://510kreport.com/methodology